Clinical Trial Quality Specialist

vor 3 Wochen

Innsbruck, Österreich MED−EL Elektromedizinische Geräte Gesellschaft m.b.H. Vollzeit

Your Tasks- Responsible for maintaining the quality system of the clinical research team, including but not limited to writing and updating clinical research SOPs, updating the CTQM and the relevant CIOMs, in compliance with the applicable regulatory framework and the company policies
- Organizing GCP-trainings for internal and external partners
- Responsible for submitting clinical investigation information in WHO databases and clinicaltrial.gov and keeping them up to date
- Coordinate appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans, and support the team leader in audit-and inspection-related activities
- Plan and conduct site-visits in accordance with the monitoring plan and provide support for study submissions in collaboration with the assigned Clinical Research Manager
- Your Profile- Bachelor’s degree or higher degree (University, FH) in clinical, science, or health-related field
- Knowledge of ISO 14155:2020, MDR, and GDPR is preferred
- Very good German and English skills, both written and spoken
- Flexible and team-oriented personality with independent working style and willingness to travel up to 20%
- Your Benefits
- Central Location- Employee Discounts- Flexible Hours- International Environment- Onboarding- Workplace Well-Being- Further information
- Minimum SalaryAnnual gross salary from
€ 48,760.78, based on professional qualification and experience, for fulltime 38.5 hours/week.
- Earliest Entry DateThis position is to be filled immediately.
- Your Contact PersonIf you have any questions please contact Marina Engl.

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